OBJECTIVE： To discuss the safety problems of the rational use of progesterone. METHODS： The occurrence， development and disposal of Progesterone injection events in 2015 in Zhejiang were analyzed， and related problems were discussed as clinical drug use and drug use monitoring. RESULTS： The rapid and manageable disposal （within 15 d） of the event demonstrated the role of ADR monitoring in discovering， reporting， assessing and controlling drug safety hazard at early stages. It also revealed problems such as the legitimacy of off-label drug use， the safety of oil injections for intramuscular injection and the insufficiency of information disclosure.  CONCLUSIONS： Off-label drug use needs legislative protection for all interest parties. Intramuscular injections using soybean oil as adjuvant needs reassessment for their quality standard and safety from the aspect of risk-benefit. Information disclosure is beneficial for ADR monitoring.